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FDA 510(k)

Cerdak Basic

K-Number: K153138 · 2017-06-23

ApplicantBu Polysciences Equipment & Trading, LLC
Decision Date2017-06-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Cerdak Basic is the device name listed in this FDA 510(k) record. The listed applicant is Bu Polysciences Equipment & Trading, LLC. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K153138. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cerdak Basic?

Cerdak Basic is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Bu Polysciences Equipment & Trading, LLC. The 510(k) number is K153138.

When did Cerdak Basic receive FDA 510(k) clearance?

Cerdak Basic received FDA 510(k) clearance on 2017-06-23, under 510(k) number K153138.

Who is the listed applicant for Cerdak Basic?

The FDA 510(k) record lists Bu Polysciences Equipment & Trading, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cerdak Basic?

The FDA product code for Cerdak Basic is FRO. This falls under the Anesthesiology category.

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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